TRACE ELEMENTS 4 injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ZINC SULFATE HEPTAHYDRATE (UNII: N57JI2K7WP) (ZINC CATION - UNII:13S1S8SF37), CUPRIC SULFATE (UNII: LRX7AJ16DT) (CUPRIC CATION - UNII:8CBV67279L), MANGANESE SULFATE (UNII: W00LYS4T26) (MANGANESE CATION (2+) - UNII:H6EP7W5457), CHROMIC CHLORIDE (UNII: KB1PCR9DMW) (CHROMIC CATION - UNII:X1N4508KF1)

Available from:

American Regent, Inc.

INN (International Name):

ZINC SULFATE HEPTAHYDRATE

Composition:

ZINC CATION 2.2 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

This formulation is indicated for use as a supplement to intravenous solutions given for TPN for children up to 11 years of age. Administration of the solution in TPN solutions helps to maintain plasma levels of zinc, copper, manganese, and chromium and to prevent depletion of endogenous stores of these trace elements and subsequent deficiency symptoms. TRACE ELEMENTS INJECTION 4, USP PEDIATRIC should not be given undiluted by direct injection into a peripheral vein because of the potential of infusion phlebitis.

Product summary:

TRACE ELEMENTS INJECTION 4, USP PEDIATRIC Each mL provides: Zinc 0.5 mg, Copper 0.1 mg, Manganese 30 mcg, and Chromium 1 mcg. NDC 0517-9310-25           10 mL Multiple Dose Vial*           Packaged in boxes of 25 *Contains 0.9% Benzyl Alcohol as an antimicrobial preservative. AMERICAN REGENT, INC. SHIRLEY, NY 11967 IN9310 Rev. 8/18

Authorization status:

unapproved drug other

Summary of Product characteristics

TRACE ELEMENTS 4- TRACE ELEMENTS 4 INJECTION, SOLUTION
AMERICAN REGENT, INC.
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
----------
TRACE ELEMENTS INJECTION 4, USP
PEDIATRIC
FOR IV USE AFTER DILUTION
RX ONLY
DESCRIPTION
TRACE ELEMENTS INJECTION 4, USP PEDIATRIC is a sterile, nonpyrogenic
solution
containing four Trace Elements for use as an additive for Total
Parenteral Nutrition (TPN).
Each mL provides: Zinc 0.5 mg, Copper 0.1 mg, Manganese 30 mcg, and
Chromium 1 mcg. Each mL
contains: Zinc Sulfate Heptahydrate 2.2 mg (equivalent to 0.5 mg
Zinc), Cupric Sulfate Pentahydrate 0.4
mg (equivalent to 0.1 mg Copper), Manganese Sulfate Monohydrate 92.3
mcg (equivalent to 30 mcg
Manganese), Chromic Chloride Hexahydrate 5.12 mcg (equivalent to 1 mcg
Chromium), and Water for
Injection q.s. pH may be adjusted with Sulfuric Acid and/or Sodium
Hydroxide. 0.9% Benzyl Alcohol is
added as an antimicrobial preservative.
CLINICAL PHARMACOLOGY
ZINC has been identified as a cofactor for over 70 different enzymes,
including carbonic anhydrase,
alkaline phosphatase, lactic dehydrogenase and both RNA and DNA
polymerase. Zinc facilitates wound
healing, helps maintain normal growth rates, normal skin hydration and
senses of taste and smell.
Providing zinc during TPN prevents development of the following
deficiency symptoms: Parakeratosis,
hypogeusia, anorexia, dysosmia, geophagia, hypogonadism, growth
retardation and
hepatosplenomegaly. At plasma levels below 20 mcg zinc/100 mL,
dermatitis followed by alopecia has
been reported for TPN patients.
COPPER is essential as a cofactor for serum ceruloplasmin, an oxidase
necessary for proper
formation of the iron carrier protein, transferrin. Copper also helps
maintain normal rates of red and
white blood cell formation. Scorbutic type bone changes seen in
infants fed exclusively with copper-
poor cow’s milk are believed due to decreased activity of asc